FDA Unveils New Plan to Stem Opioid Overdoses

There were 18 893 deaths involving prescription opioids in the US in 2014.

The US Food and Drug Administration (FDA) this week announced a new plan to refocus its efforts on curbing opioid-related deaths.

There were 18 893 deaths involving prescription opioids in the US in 2014, up 16% from 2013, according to the National Center for Health Statistics (NCHS). The administration believes synthetic opioids contributed to the increase in prescription opioid-related deaths. Deaths involving drugs like fentanyl and tramadol increased by 79% from 2013-2014.

Dr Robert Califf, MD, the FDA's deputy commissioner for Medical Products and Tobacco, along with other leaders from the agency, called for additional policy initiatives to address the country's epidemic.

"We are determined to help defeat this epidemic through a science-based and continuously evolving approach," he said in a statement. "This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis."

Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public health effects.

Convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties.

Assemble and consult with the Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved.

Develop changes to immediate-release opioid labeling, including additional warnings and safety information that incorporate elements similar to the extended-release/long-acting (ER/LA) opioid analgesics labeling that is currently required.